Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX) (HORIZON I)
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ClinicalTrials.gov Identifier: NCT00278889 |
Recruitment Status
:
Completed
First Posted
: January 19, 2006
Results First Posted
: October 24, 2012
Last Update Posted
: October 24, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: AZD2171 Drug: 5-fluorouracil Drug: Leucovorin Drug: Oxaliplatin Drug: Bevacizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 215 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Study to Compare the Efficacy of AZD2171 in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-line Treatment of Patients With Metastatic Colorectal Cancer |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | November 2007 |
Actual Study Completion Date : | October 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Bevacizumab + FOLFOX
|
Drug: 5-fluorouracil
intravenous infusion
Other Name: 5-FU
Drug: Leucovorin
intravenous infusion
Drug: Oxaliplatin
intravenous infusion
Other Name: Eloxatin®
Drug: Bevacizumab
intravenous infusion
Other Name: Avastin®
|
Experimental: 2
AZD2171 + FOLFOX
|
Drug: AZD2171
oral tablet
Other Names:
Drug: 5-fluorouracil
intravenous infusion
Other Name: 5-FU
Drug: Leucovorin
intravenous infusion
Drug: Oxaliplatin
intravenous infusion
Other Name: Eloxatin®
|
- Progression Free Survival [ Time Frame: Randomisation to data cut-off date of November 2007 ]Number of months from randomisation to the earlier date of objective progression or death
- Objective Response Rate [ Time Frame: Randomisation to data cut-off date of November 2007 ]
Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST.
- Overall Survival [ Time Frame: Randomisation to data cut-off date of 30 January 2009 ]Number of months from randomisation to the date of death from any cause
- Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI) [ Time Frame: Randomisation to data cut-off date of November 2007 ]Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires
- QOL: Time to Worsening of Treatment-free Survival (TFS) [ Time Frame: Randomisation to data cut-off date of November 2007 ]Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires
- QOL: Time to Worsening of Clear Cell Sarcoma (CCS) [ Time Frame: Randomisation to data cut-off date of November 2007 ]Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
- QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI) [ Time Frame: Randomisation to data cut-off date of November 2007 ]Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of colon or rectal cancer,
- Received prior systemic therapy for cancer,
- Cancer must have progressed during or after first treatment
Exclusion Criteria:
- Prior treatment with a VEGF inhibitor,
- Poorly controlled hypertension

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278889

Austria | |
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Innsbruck, Austria | |
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Wels, Austria | |
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Wien, Austria | |
Belgium | |
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Bonheiden, Belgium | |
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Brussels, Belgium | |
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Edegem, Belgium | |
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Gent, Belgium | |
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Leuven, Belgium | |
Canada, Manitoba | |
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Winnipeg, Manitoba, Canada | |
Canada, New Brunswick | |
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Moncton, New Brunswick, Canada | |
Canada, Ontario | |
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Kingston, Ontario, Canada | |
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Ottawa, Ontario, Canada | |
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Sudbury, Ontario, Canada | |
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Toronto, Ontario, Canada | |
Canada, Quebec | |
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Montreal, Quebec, Canada | |
Czech Republic | |
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Chomutov, Czech Republic | |
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Nova Ves Pod Plesi, Czech Republic | |
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Pardubice, Czech Republic | |
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Praha, Czech Republic | |
France | |
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Montpellier, France | |
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Saint Herblain, France | |
Germany | |
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Berlin, Germany | |
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Freiburg, Germany | |
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Halle, Germany | |
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Hannover, Germany | |
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Heidelberg, Germany | |
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München, Germany | |
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Stuttgart, Germany | |
Italy | |
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Genova, Italy | |
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La Torretta, Italy | |
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Milano, Italy | |
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Napoli, Italy | |
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Rozzano, Italy | |
Spain | |
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A Coruña, Spain | |
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Barcelona, Spain | |
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Madrid, Spain | |
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Valencia, Spain | |
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Zaragoza, Spain | |
United Kingdom | |
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Glasgow, United Kingdom | |
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Ipswich, United Kingdom | |
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Maidstone, United Kingdom | |
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Newcastle-upon-tyne, United Kingdom | |
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Sutton, United Kingdom |
Study Director: | Jane Robertson | AstraZeneca |
Additional Information:
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00278889 History of Changes |
Other Study ID Numbers: |
D8480C00041 EUDRACT number 2005-003443-31 HORIZON I |
First Posted: | January 19, 2006 Key Record Dates |
Results First Posted: | October 24, 2012 |
Last Update Posted: | October 24, 2012 |
Last Verified: | September 2012 |
Keywords provided by AstraZeneca:
Colorectal Cancer phase II metastatic colorectal cancer AZD2171 RECENTIN |
Additional relevant MeSH terms:
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Bevacizumab Oxaliplatin Cediranib |
Fluorouracil Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Protein Kinase Inhibitors Enzyme Inhibitors |